# K072816: Niox Mino

- Pathway: 510(k) (Traditional)
- Applicant: Aerocrine AB
- Decided: Mar 3, 2008 after 153 days
- Product code: MXA (System, Test, Breath Nitric Oxide)
- Device class: 2
- Regulation: 21 CFR 862.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN030001 (2003). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN030001: Niox Article NO: 02-1000, Aerocrine AB (2003). Our reading of the summary gave K021133, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN030001, Niox Article NO: 02-1000 (Aerocrine AB), granted Apr 30, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K101034: Niox Mino Model 09-1000 (2010), 5 descendants of its own
- K133898: Niox Vero Airway Inflammation Monitor (2014), 3 descendants of its own
- K182874: Fenom Pro Nitric Oxide Test (2019), 2 descendants of its own
- K150233: NIOX VERO Airway Inflammation Monitor (2015), 2 descendants of its own
- K213611: Fenom Pro (2023), 1 descendant of its own

## Indications for use
NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FENo), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FENO by NIOX MINO is a quantitative, non-invasive, simple and safe method to measure the decrease in FENO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FENO levels. NIOX MfNO is suitable for children, approximately 7 - 17 years, and adults 18 years and older. FENO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. NIOX MINO should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MiNO should not be used in critical care, emergency care or in anaesthesiology.

Source page: https://510kreport.com/device/K072816
Methodology: https://510kreport.com/methodology